Data / Medical devices / United States / Personal Genome Diagnostics Inc.
Personal Genome Diagnostics Inc.: FDA-registered device maker in Baltimore, MD, United States, 2 510(k) clearances and 1 PMA approval
Personal Genome Diagnostics Inc. is registered with the FDA (registration 3011805506) in Baltimore, MD, United States. It lists 6 device types. The FDA files 2 510(k) clearances and 1 PMA approval under its listings, the newest dated July 30, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3011805506
- Address
- 3600 Boston Street, Baltimore, MD, United States, 21224
- Owner or operator
- Personal Genome Diagnostics (10059661)
- Roles
- Manufacturer, Manufacturer for export
- First device listed
- February 26, 2019
- Registered through
- 2027
- Brand names listed
- PGDx elio diversiPhi, PGDx elio plasma focus Dx, PGDx elio tissue complete, PGDx elio tissue complete CDx
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| High Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-Free Nucleic Acids | SBY | 2 | Manufacturer | accessdata.fda.gov |
| Next Generation Sequencing Based Tumor Profiling Test | PZM | 2 | Manufacturer | accessdata.fda.gov |
| Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System | PQP | 3 | Manufacturer | accessdata.fda.gov |
| Reagents For Molecular Diagnostic Test Systems | PFT | 1 | Manufacturer | accessdata.fda.gov |
| Synthetic Next-Generation Sequencing Quality Control And Filler Material | QFI | N | Manufacturer for export | accessdata.fda.gov |
| Tumor Gene Profiling Test | QFK | N | Manufacturer for export | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 1, 2024 | DEN230046 | PGDx elio plasma focus Dx | SBY | Unknown | Personal Genome Diagnostics, Inc. | accessdata.fda.gov |
| April 24, 2020 | K192063 | PGDx elio tissue complete | PZM | Substantially Equivalent | Personal Genome Diagnostics | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| July 30, 2026 | P250036 | PGDx elio tissue complete CDx | PQP | 0 | July 30, 2026 | accessdata.fda.gov |
Compare with other makers
- All makers of Next Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System
- All makers of Reagents For Molecular Diagnostic Test Systems
- All makers of Next Generation Sequencing Based Tumor Profiling Test
Updated July 30, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.